A clinical study of MK-5684 in people with certain solid tumors (MK-5684-015)

Prior treatment

• (Cohort A) Breast cancer amenable to treatment with curative intent.
• Has any prior history or current condition of adrenal insufficiency.
• Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
• Has not adequately recovered from major surgery or has ongoing surgical complications.
• (Cohorte B)Has platinum-resistant ovarian cancer (defined as disease that has progressed per radiographic imaging within 180 days after the last dose of first-line [1L] platinum-based therapy) or platinum-refractory ovarian cancer (defined as disease that has progressed per radiographic imaging while receiving or within 28 days of the last dose of 1L platinum based therapy).
• (Cohorte C) Is a candidate for curative-intent surgery or curative-intent radiotherapy.

Other illness

• HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease.
• Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
• Has a history of stem cell/solid organ transplant.
• (Cohort B) Has nonepithelial cancers (germ cell tumors and sex cord-stromal tumors), borderline tumors (low malignant potential), mucinous, seromucinous that is predominantly mucinous, malignant Brenner’s tumor, low-grade serous, low-grade endometrioid, and undifferentiated carcinoma.
• (Cohort B) Is a candidate for curative-intent surgery or curative-intent radiotherapy for ovarian cancer.
• Has known difficulty in tolerating oral medications, unable to swallow orally administered medication, or conditions which would impair absorption of oral medications.

Other

• Has known active central nervous system metastases and/or carcinomatous meningitis.
• (Cohort A) Has advanced/metastatic, symptomatic visceral spread at risk of rapidly evolving into life-threatening complications, such as lymphangitic lung metastases, radiographic evidence of intratumoral cavitation or invasion/infiltration of a major blood vessel, bone marrow replacement, carcinomatous meningitis, significant symptomatic liver metastases, symptomatic pericardial effusion, symptomatic peritoneal carcinomatosis, or the need to achieve rapid symptom control.
• (Cohort C) Has high-grade (FIGO Grade 3 or poorly differentiated) endometroid carcinoma and nonendometrioid histologies of any type (including serous, clear cell, mixed, carcinosarcoma), and neuroendocrine tumors are not eligible. Uterine mesenchymal tumors such as an endometrial stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas, and adenosarcomas are not eligible.
• Has confirmed or suspected adrenal metastases.

• (Cohort A) Has a diagnosis of hormone receptor positive/Human Epidermal Growth Factor Receptor 2 negative invasive breast carcinoma that is either locally advanced disease not amenable to resection with curative intent (herein called unresectable) or metastatic disease not treatable with curative intent.
• Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable.
• (Cohort A) Has experienced disease progression on or after at least 1 prior endocrine-based therapy in the metastatic setting and received either, 1 line of an approved protocol-specified combination endocrine-based therapy, or 2 or more lines of protocol-specified endocrine-based therapy in the metastatic setting.
• (Cohort B) Has histologically confirmed high-grade epithelial (including high-grade serous or predominantly serous, high-grade endometrioid, malignant mixed Müllerian tumors [carcinosarcoma], or clear cell) ovarian, fallopian tube, or primary peritoneal carcinoma.
• (Cohort B) Has received between 4 to 8 cycles of platinum-based doublet chemotherapy in third-line setting for ovarian cancer.
• (Cohort C) Histologically confirmed diagnosis of primary advanced or recurrent low-grade endometrioid carcinoma (eg, Federation of Gynecology and Obstetrics [FIGO] Grade 1/2, or well/moderately differentiated).
• (Cohort C) Treatment naïve or has received up to 1 prior line of platinum-based therapy in either the advanced/metastatic OR adjuvant/neoadjuvant setting.
• Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline.
• Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy.
• Participants who are Hepatitis B surface antigen positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load.